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Man Versus Machine: Is There an Optimal Method for QT Measurements in Thorough QT Studies?
Author(s) -
Darpo Borje,
Agin Marilyn,
Kazierad David J.,
Layton Gary,
Muirhead Gary,
Gray Peter,
Jorkasky Diane K.
Publication year - 2006
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006286900
Subject(s) - qt interval , medicine , placebo , electrocardiography , outlier , pairwise comparison , anesthesia , statistics , cardiology , mathematics , alternative medicine , pathology
Electrocardiographic (ECG) recordings from 3 placebo‐controlled thorough QT healthy volunteer studies were used to compare QT intervals obtained by manual measurement with those generated by ECG machines. The effect of the positive control was compared to placebo at each time point for data obtained from both sources. Both manual and automated techniques consistently demonstrated statistically significant prolongation of QTcF with the positive controls. The proportion of outlier values was small for both methods. The pairwise comparison between manual and automated uncorrected QT intervals demonstrated clear differences, with intervals derived from one machine on average 16 to 19 milliseconds shorter and from the other 7 milliseconds longer than the manually measured QT intervals, but these differences disappeared when analyzing QT change from baseline. Both manual and automated, commercially available QT algorithms demonstrated small statistically significant effects on the QTc interval induced by positive controls.